Trial document




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  DRKS00011155

Trial Description

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Title

Ethical and Legal Framework for Predictive Diagnosis of Alzheimer’s Disease: Quality of Life of Individuals at Risk and their Close Others (PreDADQoL)

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Trial Acronym

PreDADQoL

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URL of the Trial

http://ceres.uni-koeln.de/forschung/projekte/predadqol/

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The project PreDADQoL aims at providing an empirically informed ethical and legal framework
and counselling guidance for predicitive diagnosis of Alzheimer's Disease (AD) in patients with mild cognitive impairment (MCI) as a condition of increased risk of AD. In addition to the focus on subjects with MCI, the ethical and legal framework and counselling guidance will include the perspective of the patients' close others (e.g. partners, children, siblings) from the beginning. Keeping in mind that disease-modifying treatments are not yet established, a normative framework will be developed in which a broad concept of quality of life and fundamental legal considerations serve as the crucial reference concept for information, counselling, decision making and care before and after predictive diagnosis of AD.
By means of quantitative and qualitative research methods this study yields to find out about attitudes and expectations as well as effects on quality of life of MCI patients and their close others before and after predictive diagnosis of AD. Furthermore the project aims at providing a guidance for the counselling and risk disclosure of MCI patients and their close others in the context of biomarker based predictive diagnosis of AD. For that purpose, based on an intensive literature research, a standardized counseling and risk disclosure guidance will be developed.
PreDADQoL is a transnational empirical project, partnering with one of Europe's largest Alzheimer Clinics, the Fundaciò ACE in Barcelona.

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Organizational Data

  •   DRKS00011155
  •   2017/08/18
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  •   yes
  •   Approved
  •   17-016, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   F06.7 -  Mild cognitive disorder
  •   F00.0 -  Dementia in Alzheimer disease with early onset
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Interventions/Observational Groups

  •   Subjects with mild cognitive impairment (MCI)

    - Standardized counseling and risk disclosure about predictive biomarker-based AD diagnosis
    - Quantitative and qualitative measurements with questionnaires and interviews
  •   Close others of MCI subjects

    - Standardized counseling and risk disclosure of the diseased relative (= MCI-patient) about predictive biomarker-based AD diagnosis
    - Quantitative and qualitative measurements with questionnaires and interviews
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Assessment of the expectations with regard to predictive diagnosis of AD in subjects with MCI and their close others (e.g. spouse, partner, children).

- The study has 4 survey time points and und 2 Intervention time points:

1) Screening

2) Intervention A: Counseling about the biomarker based AD diagnosis

2) Baseline visit

3) Intervention B: Risk disclosure about the individual risk of developing AD

4) Visit 1 (1 week after risk disclosure)

5) Visit 2 (3 months after risk disclosure)

Administration of the following questionnaires:

- Mini-Mental State Examination - MMSE
- Geriatric Depression Scale – GDS
- Geriatric Anxiety Inventory – GAI
- Structured Clinical Interview - SCID-I
- Resources Utility Questionnaire LITE – RUD
- Functional Activities Questionnaire – FAQ
- Columbia- Suicide Severity Rating Scale - C-SSRS
- Positive and Negative Affect Schedule – PANAS
- Flex-Ten Scale short version
- Subjective Numeracy Scale
- Satisfaction with Life Scale – SWLS
- Fragen zur Lebenszufriedenheit – FLZM
- WHOQoL Bref
- Questionnaire about the personal risk belief
- Questionnaire about the personal risk recall
- Questionnaire about lifestyle
- Questionnaire about spirituality
- Questionnaire about the expectations towards the predictive AD diagnosis

Furthermore qualitative interviews are performed with the MCI patients and their caregivers.

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Secondary Outcome

- Assessment of the effects of predictive diagnosis of AD on psychological distress, subjective well-being and quality of life in subjects with MCI and their close others (e.g. spouse, partner, children)

-Elaborate an empirically based ethical and legal framework with regard to predicitve diagnosis of Alzheimer's Disease in patients with MCI

- Development of a guideline for information and counselling of subjects with MCI and their close
others

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Countries of Recruitment

  •   Germany
  •   Spain
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2017/09/15
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   no maximum age
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Additional Inclusion Criteria

For both study arms:
•Clinical criteria for late amnestic mild cognitive impairment due to Alzheimers Disease (according to criteria of National Institute on Aging–Alzheimer's Association ):
-Performance of 1.5 Standard deviation below the normative mean in one memory test
-Single or multiple domain impairment
-Cognitive concern reflecting a change in cognition reported by patient or informant or clinician
-Preservation of independence in functional abilities
•Written informed consent from patient prior to any study procedures. All patients must be able to give informed consent personally and have capacity for such consent.
•Patients must have a reliable close other, who is in close contact with the patient and able to contribute to the questionnaires and rating scales at the study visits. This person must sign a separate informed consent form which describes their contributions during the study.
•Patients must have fluency in the test language.
•Age ≥ 55 years

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Exclusion Criteria

For both study arms:
•Dementia
•Evidence of non-Alzheimer's neurodegenerative disorder: parkinson's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, very rapid cognitive decline that occurs over weeks or months (typically indicative of prion disease, neoplasm, or metabolic disorders)
•Brain tumor
•Presence of extensive cerebrovascular disease on structural brain images, which is suggestive of vascular cognitive impairment
•Clinical relevant depressive symptoms (geriatric Depression scale >11), clinical relevant anxiety symptoms (geriatric anxiety inventory >11) and suicidality
• Absent caregiver/informant
•Illiteracy
•Contraindication for lumbar puncture

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Addresses

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    • Cologne Center for Ethics, Rights, Economics and Social Sciences of Health (ceres),Universität zu Köln
    • Ms.  Prof. Dr.  Christiane   Woopen  
    • Albert-Magnus-Platz
    • 50932  Köln
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Köln (AöR)
    • Mr.  Prof. Dr.  Frank  Jessen 
    • Kerpener Str 62
    • 50937  Köln
    • Germany
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    • Cologne Center for Ethics, Rights, Economics, and Social Sciences of Health (ceres), Universität zu Köln
    • Ms.  Prof. Dr.   Christiane   Woopen 
    • Albertus-Magnus-Platz
    • 50923  Köln
    • Germany
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    • Cologne Center for Ethics, Rights, Economics, and Social Sciences of Health (ceres)
    • Ms.  M.A.  Carolin  Schwegler 
    • Albert-Magnus-Platz
    • 50932  Köln
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr. med.  Ayda  Rostamzadeh 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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